Transcript Hess Presentation - Alliance for Health Reform

Pharmaceutical Policy and Pricing:
How are Countries Getting Greater Value?
Commonwealth Fund/ Alliance for Health Reform
Briefing on Capitol Hill
Dr. jur. Rainer Hess
Federal Joint Committee, Germany (G-BA)
Page 1 | 7th November 2011 |
Commonwealth Fund/ Alliance for Health Reform
© 2011, Dr. jur. Rainer Hess
Pharmaceutical Policy
and Pricing
Development of RX drug sales and prices
(index Q1/2007)
Generic drugs
150
On patent drugs
packages
150
140
expenses
130
price per package 130
120
120
110
110
100
100
90
90
80
80
Source:
140
NVI (INSIGHT Health); pharmacy retail prices (Apothekenverkaufspreise).
Page 2 | 7th November 2011 |
Commonwealth Fund/ Alliance for Health Reform
© 2011, Dr. jur. Rainer Hess
Pharmaceutical Policy
and Pricing
Legal Framework for Healthcare established by
law and the Ministry of Health
“Decision Platform“
Federal Joint Committee (G-BA)
C.
A.
B.
Advisory
membership
Commissioning
Institut for Quality
and Efficiency
(IQWiG)
C. State/Federal
Sickness
Fund-Ass.
B. State/Federal
Hospital
organisation
A.State/Federal
Physicians‘
organisation
Patient / Insuree
Page 3 | 7th November 2011 |
Commonwealth Fund/ Alliance for Health Reform
Patient
Organisations
for defining the
services delivered
as statutory
health insurance
Industry:
Transparency of
assessments and
drafts of decisions;
written and oral
hearings; justified
decisions; right to
sue
© 2011, Dr. jur. Rainer Hess
Pharmaceutical Policy
and Pricing
Pharmaceutical steering tools:
1. Federal level:
 Reference price setting for comparable drugs including
patented drugs
 Early assessment of new pharmaceutical agents within 6
months after market access and based on the assessed value
(started in 2011)
 Negotiation or setting of a reimbursement price 12 months
after market access (starts in 2012)
 Exclusion of drugs in case of inappropriateness compared with
treatment alternatives
 OTC-exemption list; lifestyle-negative list
Page 4 | 7th November 2011 |
Commonwealth Fund/ Alliance for Health Reform
© 2011, Dr. jur. Rainer Hess
Pharmaceutical Policy
and Pricing
Pharmaceutical steering tools:
2. State level:
 Negotiation of savings goals on the basis of DDDrecommendations
 IT-based drug prescribing check of physicians
 Discount negotiations between sickness funds and
pharmaceutical companies based on tendering procedures
including the possibility of risk-sharing and price-volume
payback agreements
 Binding on the pharmacists to dispend a discount negotiated
drug, if the physician does not exclude “aut similar.”
Page 5 | 7th November 2011 |
Commonwealth Fund/ Alliance for Health Reform
© 2011, Dr. jur. Rainer Hess
IQWIQ
Evaluation
request
Control and
G-BA
assessment
Pharmaceutical Policy
and Pricing
Prepares
assessment
We are here
Hearing
manuf.
experts
Submits
dossier
Add.
Benefit
Manufacturer
G-BA
G-BA
Market
access
Efficiency
assessment
(published)
Efficiency
assessment
decision
No add.
Benefit
Manufacturer’s
price
Free price
setting
Not
accepted
No
agreement
Manufact./
Head associa.
statutory
health ins.
Arbitration
authority
IQWIQ
Price
negotiation
Arbitral
verdict
Cost-benefit
assessment
Agreement
No reference
price applicable
Valid until the end
of the procedure
Retroactive
Reference price
Rebate
Maximum GKV
reimbursement
price
Freely decided
on
Rebate
On ex-factory
price
Market access
3 months
Page 6 | 7th November 2011 |
6 months
Commonwealth Fund/ Alliance for Health Reform
12 months
15 months
© 2011, Dr. jur. Rainer Hess
Pharmaceutical Policy
and Pricing
2. Reference
prices
1. Early benefit
assessment of new
pharmaceuticals
3. Reimbursement price
agreements for new
pharmaceuticals with
additional benefit
Free market access
of a new pharmaceutical
8. OTC
exemption list
4. Cost-benefit
assessment
(second line)
Health care research/
Health care studies
5. Subsequent
benefit assessment
7. Therapeutical
advice
6. Prescription
restrictions
Page 7 | 7th November 2011 |
Commonwealth Fund/ Alliance for Health Reform
© 2011, Dr. jur. Rainer Hess
Pharmaceutical Policy
and Pricing
•
Benefit-package decisions must be justified by an evidencebased process to determine whether services, pharmaceuticals or
technologies are medically effective to reach patient relevant
objectives: morbidity, mortality and life-quality.
•
Evidence based assessments in Germany only could be used to
select the most appropriate (efficient) service etc. from others; if a
costly innovation has a significant additional benefit, the sickness
funds must pay for it (rationalizing not rationing).
Page 8 | 7th November 2011 |
Commonwealth Fund/ Alliance for Health Reform
© 2011, Dr. jur. Rainer Hess